CHMP recommends approval of Jinarc in ADPKD-Otsuka Pharmaceutical
The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended Jinarc (tolvaptan), from Otsuka Pharmaceutical, for approval to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with chronic kidney disease (CKD) stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease.
The recommendation is based on data from the largest clinical study conducted in ADPKD to date – the pivotal phase III randomised, double-blind and placebo-controlled TEMPO 3:4 trial. In the three-year trial, tolvaptan achieved its primary endpoint, demonstrating a statistically significant reduction of almost half (49%) in the annual increase in total kidney volume versus placebo. Furthermore, the study showed tolvaptan significantly reduced the decline in kidney function by 30% versus placebo. The overall incidence of side effects observed in ADPKD patients administered tolvaptan in the TEMPO 3:4 trial was comparable with those administered a placebo. A final EC decision is expected during the second quarter of 2015.
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